Active Injury Management (AIM) After Pediatric Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 4
- 主要终点
- Change in Post-Concussion Symptoms Scale (PCSS)
研究概览
简要总结
The proposed interventions of this study will determine the ideal discharge recommendations related to activity
详细描述
The investigators will conduct a phase II factorial clinical trial . The clinical trial will determine the benefit of prescribed low-intensity physical activity, behavioral management, or both, versus standard rest in acute (24-48 hrs) (Moderate Traumatic Brain Injury (mTBI) patients presenting to the pediatric Emergency Department (ED). Low-intensity physical activity (i.e.10,000 steps/day) will be prescribed and monitored in the first week post-injury with an actigraph (Fitbit®). Behavioral management will be prescribed using a phone app referred to as mHealth (mobile Health, specifically SuperBetter©) that promotes mental, physical, social, and emotional resilience. This randomized clinical trial will have four treatment groups: 1) activity, 2) mHealth, 3) activity+mHealth, 4) rest. The primary study outcomes will be symptoms and recovery by 14 days. All subjects will be assessed via phone at 3-5 days and in person at 14 days. The secondary outcomes will be to determine the influence of interventions on comprehensive aspects of physiologic recovery and patient-centered outcomes; including symptoms at 3 days, neurocognitive, vestibular/ocular motor impairment at 14 days, pediatric quality of life measures, time to symptom resolution, and return to normal activity via phone survey at 1 and 2 months. The investigators will assess symptom, quality of life, and recovery outcomes based on treatment group assignment for all subjects and high-risk subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mTBI in the past 72 hours
排除标准
- •Patients having conditions otherwise which limit physical activity or neurocognitive assessment
- •Do not have a smart phone
- •History of brain surgery or past moderate/severe TBI within the last 6 months,
- •Substance abuse,
- •Major psychiatric condition under ongoing treatment with medications,
- •Vestibular disorder,
- •Cardiac condition,
- •Unable to provide consent/assent
- •Previous enrollment in the study
结局指标
主要结局
Change in Post-Concussion Symptoms Scale (PCSS)
时间窗: Day 0, Day 10-14
Post-concussive symptoms at 14 days will be assessed using the Post-Concussion Symptom Scale (PCSS). We chose the 22-item PCSS as it is commonly used and would ensure consistency in longitudinal comparisons. The PI has validated PCSS administration via phone. The PCSS comprises 22 self-reported symptoms (e.g., dizziness headache) rated on a scale from 0 (none) to 6 (severe). PCSS score of ≤ 7 will be defined as symptom recovery. The PCSS takes 5 min to complete.
Fitbit Flex 2 Actigraph
时间窗: Day 0-14
The Fitbit Flex 2 Actigraph will be distributed from the ED for all subjects in the study. Fitbit Actigraphs have been utilized in over 300 published studies. The Fitbit Flex 2 device to be worn by all subjects will provide objective activity metrics including measures of physical activity (e.g., number of steps per day, active minutes, distance traveled) and sleep (e.g., time to fall asleep, time sleeping, restless time). The Fitbit Flex 2 has a up to 5 days of battery life (device reminds subjects when battery life is low). The device 5 LEDs can be utilized to remind subjects to move, remind of current step goals, and celebrate when the goal is met. These features will be activated for subjects in the ACTIVITY groups. These data will be extracted directly from each device through Fitbit's API (Application Programming Interface. Allows devices to communicate with other select devices) system. These data will be collected in the first 14 days postinjury.
Change in Pediatric Quality of Life Measures (PedsQL)
时间窗: Day 0, Day 10-14,
We will assess health-related quality of life at 14 days using the PedsQL, a validated tool that has been used in healthy children and adolescents and those with acute and chronic health conditions. PedsQL has been demonstrated to show differences between subjects with persistent symptoms and those without up to 12 weeks post-concussion. The PedsQL measures have reliability and validity in assessing and comparing health-related quality of life scores between groups. They are agespecific and can be administered to parents and children and have been used to assess functional outcomes over time. The inventory includes 23 items rated from 0 (never) to 4 (almost always) and takes less than 5 min to complete.
次要结局
- Symptom Tracking Assessment for Concussion (STAC) application(Day 0-14)
- Immediate Post-Concussion Assessment and Cognitive Test (ImPACT)(Day 0, Day 10-14,)
- International Activity Questionnaire (IPAQ)(Day 0, Day 10-14, Day 30, Day 60)
- Vestibular/Ocular Motor Screen (VOMS)(Day 0, Day 10-14,)
- Brief Symptom Inventory-18 (BSI-18)(Day 3-5, Day 30, Day 60)
- Screen Time Assessment(Day 0 - 14)
- Modified Balance Error Scoring System (mBESS)(Day 0, Day 10-14,)
研究者
Danny Thomas
Associate Professor Pediatric Emergency Medicine
Medical College of Wisconsin